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RECRUITING
NCT04384341
NA

Haemophilia and Bone Loss - PHILEOS Study

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

View on ClinicalTrials.gov

Summary

Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot formation, causing excessive bleeding (mainly haemarthrosis). Osteoporosis is a systemic bone disease characterized by a low bone mineral density (BMD). A decrease of mean BMD has been described in haemophilic patients compared to healthy controls in several studies. So, osteoporosis could be an underestimated haemophilia-related comorbidity. None of the following risk factors (reduced physical activity, joint damage, vitamin D deficiency and /or hepatitis C virus (HCV) infection) has been retained as a cause of osteoporosis in haemophilic patients. Another hypothesis is that bone loss could be directly linked to fVIII or fIX and/or thrombin deficiency. The aim of this study is to evaluate the prevalence of the bone loss in HA and B patients, according to the type, the severity and the presence (or not) of a prophylactic treatment (depending on the age at which it was began) and to compare it to a control population. The investigators will also evaluate the relation between BMD and FVIII, fIX and thrombin potential.

Official title: Haemophilia and Bone Loss PHILEOS Study

Key Details

Gender

MALE

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2020-06-02

Completion Date

2025-03

Last Updated

2025-04-01

Healthy Volunteers

Yes

Conditions

Interventions

RADIATION

Bone densitometry (BMD)

Recruitment of haemophilic patients during a routine visit at the haemophilia centre. Information of the subjects that the study requires a BMD measure for all and a blood sampling for patients only. After inclusion and exclusion criteria have been checked, the subject can sign the consent. For all subjects, an appointment will be made for BMD measure. For patients and controls: BMD will be measured by Dual Energy X-ray Absorptiometry (DXA) technology, on femoral and lumbar spine (L2-L4) sites. Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements.

BIOLOGICAL

Blood sampling for patients only

For patients, fVIII/fIX activity and antigen, thrombin generation potential and plasmatic markers of bone remodelling will be measured centrally.

Locations (23)

BELGIUM - Brussels

Brussels, Belgium

University Hospital Centre Zagreb

Zagreb, Croatia

Chu de Bordeaux

Bordeaux, France

Chu Brest Hopital Morvan

Brest, France

HCL - Groupement Hospitalier Est (Hôpital Louis Pradel)

Bron, France

CHU Caen

Caen, France

Centre Hospitalier Metropole Savoie

Chambéry, France

Chu Cth Estaing Clermont Ferrand

Clermont-Ferrand, France

Chu de Dijon

Dijon, France

Chu Grenoble Alpes

Grenoble, France

CHU Lille

Lille, France

Chu La Timone Marseille

Marseille, France

CHU - Saint Eloi

Montpellier, France

CHU Nancy

Nancy, France

CHU de Nantes

Nantes, France

Chu Necker Paris

Paris, France

APHP - Bicêtre

Paris, France

Chu Rennes Hopital Pontchaillou

Rennes, France

CHU de ROUEN

Rouen, France

CHU de Saint-Etienne

Saint-Etienne, France

Chu Strasbourg - Hôpital de Hautepierre

Strasbourg, France

MHEK

Budapest, Hungary

ROMANIA - Bucharest

Bucharest, Romania